ISO 13485:2016 Lead Auditor
In this comprehensive course, participants will gain an in-depth understanding of the ISO13495:2016 and ISO19011 standards and their application in the Medical Device Industry. Through a combination of lectures, practical exercises, and case studies, participants will become proficient as ISO13485:2016 Lead Auditors.
Key topics covered in the course include:
- ISO13485:2016 Standard
- Principles of Auditing – ISO 19011
- Audit planning, preparation, and execution
- Documentation review and assessment
- Audit reporting and corrective action follow-up
- Ethical considerations and professional conduct in auditing
- Conflict resolution during an audit
- Leading Audit Teams
- Case studies and real-world examples
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